NDA 15500, held by Pharmacia And Upjohn. Tolazamide.
As of Nov 13, 2026, NDA 15500 (Tolinase), held by Pharmacia And Upjohn, was first approved by FDA on Jul 18, 1966, with 9 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 18, 1966 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Tolinase100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Tolazamide | DiscontinuedReference drug |
| Tolinase250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Tolazamide | DiscontinuedReference drug |
| Tolinase500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Tolazamide | DiscontinuedReference drug |
| Oct 28, 1999 | Supplement 50Labeling · Standard review | Approved | None posted |
| Jun 25, 1987 | Supplement 48Labeling | Approved | None posted |
| Jun 25, 1987 | Supplement 47Labeling | Approved | None posted |
| Jul 11, 1986 | Supplement 46Manufacturing · Priority review | Approved | None posted |
| Mar 24, 1986 | Supplement 45Labeling | Approved | None posted |
| Oct 3, 1984 | Supplement 43Labeling | Approved | None posted |
| May 9, 1983 | Supplement 42Manufacturing · Priority review | Approved | None posted |
| Feb 24, 1978 | Supplement 40Labeling | Approved | None posted |
| Dec 1, 1975 | Supplement 34Manufacturing · Priority review | Approved | None posted |
| Jul 18, 1966 | Original applicationNew molecular entity · Priority review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
